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BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer


Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50%
in HER2+ patients without exposing patients to the toxicity of an anthracycline-based
regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming
an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be
inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients.
With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate
a pCR rate exceeding 50% for our novel regimen.


Inclusion Criteria:



- Histologically documented adenocarcinoma of the breast

- ANC > 1000 cells

- Female; age > 18; Zubrod PS 0-1

- Platelets > 100,000

- Stage IIA-IIIB disease

- Total bilirubin < or = ULN

- No evidence of metastatic disease Not pregnant or lactating

- No prior systemic therapy for this breast cancer

- Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min

- Serum ALT < 2.5 x ULN

- ER, PR and HER2 status required

- LVEF (MUGA/echo)WNL

- No baseline > 2 neuropathy

- Hemoglobin > 9.0 gm/dl

- HER2+, defined by IHC 3+ or FISH ratio > 2.0

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the clinical and pathologic response rates, particularly the pCR/near pCR rate, observed following treatment with q3week carboplatin, weekly Abraxane and weekly trastuzumab in resectable and unresectable LABC;

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

William Sikov, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University

Authority:

United States: Institutional Review Board

Study ID:

BrUOG-BR-211B

NCT ID:

NCT00617942

Start Date:

February 2008

Completion Date:

December 2017

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Brown University Oncology GroupProvidence, Rhode Island  02912
City of HopeDuarte, California  91010